Effect of Tranexamic Acid in Upper Gastrointestinal Bleeding

Effect of Tranexamic Acid on Blood Transfusion in Upper Gastrointestinal Bleeding

The investigators hypothesize that addition of Tranexamic acid, an antifibrinolytic agent, to conventional therapy will lead to an improved outcome characterized by lower transfusion requirements.

Study Overview

• Status: Withdrawn
• Conditions: Gastrointestinal Hemorrhage
• Intervention / Treatment: Drug: tranexamic acid; Other: Placebo

Detailed Description

After informed consent is obtained patients will be randomized to receive either Tranexamic acid or placebo in additional to conventional therapy. All patients with gastrointestinal hemorrhage who are admitted to the ICU are managed in consultation with the GI physicians. The ICU team in consultation with the gastroenterology team will manage these patients. Tranexamic acid will be administered in a dose of 1 gm intravenously every 6 hours for four days.

The majority of patients with GI bleeding will spontaneously stop bleeding. However, in those patients that do not and are hemodynamically unstable it poses a significant management challenge. Management of these individuals includes resuscitation followed by endoscopy as well as therapy guided by clinical diagnosis. With optimal therapy mortality in these individuals remains high and the amount of blood transfusion on occasions turns out to be massive and often the outcomes are futile. Tranexamic acid is an antifibrinolytic agent that has been shown to be associated with reduced bleeding and transfusion requirement in surgical patients. We would like to randomize patients to receive either Tranexamic acid or placebo in addition to conventional therapy and monitor outcome.

This study should provide us with information about the efficacy of this medicine in patients with upper GI bleeding. Data from this trial will provide us information about utility of pursuing this modality of therapy.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All patients with GI bleed if the following criteria are met:

  • has received 4 units of PRBCs within a 24-hour period, or
  • has orthostatic hypotension (drop in SBP of 20mmHg or drop in DBP of 10mmHg after fluid resuscitation with at least 20ml/Kg of either isotonic fluid and/or PRBCs), or
  • if the MAP remains below 60mmHg after fluid resuscitation, and
  • written informed consent is obtained from the subject or legally authorized representative.

Exclusion Criteria:

• Pregnant or lactating women
• Known to have gastrointestinal malignancy
• On anticoagulation therapy
• Patients with history of thromboembolism
• Patients with history of myocardial infarction or ischemic cerebrovascular accident
• Patient with end stage renal disease
• Patients with DNR status
• Incarcerated individuals

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Tranexamic acid arm	Drug: tranexamic acid; 1 gm every 6 hours for 4 days via IV for non-renal impaired subjects. Alternate IV dosing for renally-impaired subjects: 10mg/Kg BID (1.36 - 2.83 mg/dl clearance); 10mg/Kg QD (2.84 - 5.66 mg/dl clearance; and 10mg/Kg Q48H or 5mg/Kg (.5.66mg/dl clearance); Other Names: Cyklokapron
PLACEBO_COMPARATOR: Control arm; Will receive a placebo in place of tranexamic acid treatment	Other: Placebo; Will receive placebo treatment as per the tranexamic acid schedule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Amount of blood transfusions needed (units of packed RBCs)	Every 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Rebleeding events	Every 6 months
Need for surgical intervention	Every 6 months
Mortality rates	Every 6 months
Length of stay in ICU	Every 6 months

Collaborators and Investigators

• Sponsor: University of Oklahoma

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Study Completion (ACTUAL): October 1, 2011

Study Registration Dates

• First Submitted: October 28, 2009
• First Submitted That Met QC Criteria: October 29, 2009
• First Posted (ESTIMATE): October 30, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): April 9, 2012
• Last Update Submitted That Met QC Criteria: April 5, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: blood transfusion; tranexamic acid; GI bleeding; upper GI bleeding
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Hemorrhage; Gastrointestinal Hemorrhage; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: 14456